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Long-Term Results of RTOG Trial 8911 (USA Intergroup 113): A Random Assignment Trial Comparison of Chemotherapy Followed by Surgery Compared With Surgery Alone for Esophageal Cancer

David P. Kelsen, Katryn A. Winter, Leonard L. Gunderson, Joanne Mortimer, Norman C. Estes, Daniel G. Haller, Jaffer A. Ajani, Walter Kocha, Bruce D. Minsky, Jack A. Roth, Christopher G. Willett

From the Memorial Sloan-Kettering Cancer Center, New York, NY; the Radiation Therapy Oncology Group Statistical Office; the University of Pennsylvania, Philadelphia, PA; Mayo Clinic Cancer Center, Scottsdale, AZ; Washington University, St Louis, MO; the University of Kansas, Lawrence, KS; The University of Texas M.D. Anderson Cancer Center, Houston, TX; Duke University, Durham, NC; and the University of Western Ontario, London, Ontario, Canada

Address reprint requests to David P. Kelsen, MD, Gastrointestinal Oncology Service, Memorial Sloan-Kettering Cancer Center, 1275 York Ave, New York, NY 10021; e-mail: kelsend{at}mskcc.org

Purpose We update Radiation Therapy Oncology Group trial 8911 (USA Intergroup 113), a comparison of chemotherapy plus surgery versus surgery alone for patients with localized esophageal cancer. The relationship between resection type and between tumor response and outcome were also analyzed.

Patients and Methods The chemotherapy group received preoperative cisplatin plus fluorouracil. Outcome based on the type of resection (R0, R1, R2, or no resection) was evaluated. The main end point was overall survival. Disease-free survival, relapse pattern, the influence of postoperative treatment, and the relationship between response to preoperative chemotherapy and outcome were also evaluated.

Results Two hundred sixteen patients received preoperative chemotherapy, 227 underwent immediate surgery. Fifty-nine percent of surgery only and 63% of chemotherapy plus surgery patients underwent R0 resections (P = .5137). Patients undergoing less than an R0 resection had an ominous prognosis; 32% of patients with R0 resections were alive and free of disease at 5 years, only 5% of patients undergoing an R1 resection survived for longer than 5 years. The median survival rates for patients with R1, R2, or no resections were not significantly different. While, as initially reported, there was no difference in overall survival for patients receiving perioperative chemotherapy compared with the surgery only group, patients with objective tumor regression after preoperative chemotherapy had improved survival.

Conclusion For patients with localized esophageal cancer, whether or not preoperative chemotherapy is administered, only an R0 resection results in substantial long-term survival. Even microscopically positive margins are an ominous prognostic factor. After a R1 resection, postoperative chemoradiotherapy therapy offers the possibility of long-term disease-free survival to a small percentage of patients.

Supported by Grants No. CA 21661, CA 62115, and CA 37422 from the National Cancer Institute, Bethesda, MD.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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